A Multi-Centre, Randomized, Placebo-controlled, Parallel-Group, Double-Blinded Study to Compare the Therapeutic Efficacy, Safety and Tolerability of 3 Single Vaginal Doses of Arasertaconazole Nitrate pessaries in the Treatment of Vulvovaginal Candidiasis
- Conditions
- Vulvovaginal CandidiasisMedDRA version: 12.1Level: PTClassification code 10047784Term: Vulvovaginal candidiasis
- Registration Number
- EUCTR2009-016655-21-CZ
- Lead Sponsor
- Ferrer Internacional, S.A
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 227
1.Women with VVC who are exhibiting at least 2 of the following clinical signs and symptoms of disease: itching, burning, irritation, edema, erythema, excoriation of the vagina, with a total score of 5 or greater (0=absent, 1=mild, 2=moderate, and 3=severe).
2.Women aged between 18 to 65 years of age who have signed the informed consent.
3.Expected menstruation period not before Day 6.
4.Not pregnant, not nursing or at least 1-year post menopausal or subjects who underwent surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy).
5.Subjects must have agreed to practice sexual abstinence for at least Visit 2 (Day 8 ± 2 days).
6.From Visit 2 to Visit 3 subjects must agree to use a condom in case of sexual intercourse.
7.After Visit 2 until Visit 3 (Day 26 ± 4 days, Test-of-Cure [TOC] Visit), the subject must agree to use or continuing use at least one of the contraceptive methods to be defined as:
•abstinence
•oral contraceptives
•other hormonal contraceptives such as skin patches or injectable hormonal medication
•mechanical products (except diaphragm) such as an intrauterine device (IUD)
8.Subjects must have agreed to use sanitary protection (ie, sanitary napkin) other than tampons if they have their menstrual period during the study.
9.No indication of other vulvovaginitis or genital infections (ie, bacterial vaginosis, Trichomonas vaginalis, Chlamydia trachomatis, Neisseria gonorrhoeae, active Herpes simplex, or human papilloma virus).
10.Positive 10% potassium hydroxide (KOH) preparation for budding yeast and/or pseudohyphae.
11.Negative wet mount results for T. vaginalis and clue cells.
12.Negative urine pregnancy test on all subjects.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
1.Previous systemic antifungal treatment within 4 weeks and topical vulvovaginal antifungal treatment within 7 days of randomization.
2.Subjects using other vulvovaginal therapeutics within 7 days of randomization.
3.Subjects who are currently using systemic antibiotics at the time of the admission visit or anticipated being treated with antibiotics during the study period.
4.Subjects who were current using or anticipated the treatment with anticoagulants during the study period.
5.Use of vaginal lubricants, foams, jellies, ointments, douches, or feminine sprays for at least 3 days before admission.
6.Subjects with previous history of intolerance to an IUD should not participate in the study.
7.Papanicolaou (PAP) smear cervical intraepithelial neoplasia grade 3 (CIN3)/carcinoma in-situ (CIS) within the previous 12 months or at admission will not be acceptable.
8.Subjects with another vaginal or vulvar condition that would confound the interpretation of clinical response.
9.Subjects who will be under treatment or surgery for gynecological pathologies during the study period, ie, cervical intraepithelial neoplasia cervical carcinoma, other neoplasms.
10.Hypersensitivity to imidazole products administered topically.
11.An inability to adhere to or understand the protocol.
12.Any other medical condition which in the opinion of the investigator could interfere with study conduct.
13.Subjects who had participated in another study (drug or device) 30 days before admission.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary objective is to determine the dose response of arasertaconazole nitrate in the treatment of VVC for Phase III clinical studies.;Secondary Objective: The secondary objective of this study is to determine the safety and tolerability of the 3 different tested doses of arasertaconazole nitrate pessaries.;Primary end point(s): Efficacy<br>•The primary efficacy endpoint for this study is the dose response for global therapeutic cure at the TOC (Visit 3).<br><br>Safety<br>•Adverse events (systemic and local)<br>•Change from baseline in physical examination at Visits 2 and 3 <br>•Change from baseline in vital signs (systolic/diastolic blood pressure and heart rate) at Visits 2 and 3. <br>•Change from baseline in ECG at Visits 2 and 3<br>•Change from baseline in laboratory tests (hematology, biochemistry, urinalysis and coagulation tests) at Visit 2<br>
- Secondary Outcome Measures
Name Time Method